{
    "info": {
        "nct_id": "NCT05220501",
        "official_title": "Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: a 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men with Clinical Suspicion of Prostate Cancer.",
        "inclusion_criteria": "* Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination\n* No history of prior prostate biopsy\n* No history of genitourinary cancer, including prostate cancer\n* 18 years or older\n* No contraindications to biopsy\n* No contraindications to mpMRI\n* No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of prior prostate biopsy\n* History of genitourinary cancer, including prostate cancer\n* Contraindications to biopsy\n* Contraindications to mpMRI",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination",
            "criterions": [
                {
                    "exact_snippets": "Men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "indicated for prostate biopsy",
                    "criterion": "prostate biopsy indication",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated Prostate Specific Antigen",
                    "criterion": "Prostate Specific Antigen level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal Digital Rectal Examination",
                    "criterion": "Digital Rectal Examination result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "abnormal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of prior prostate biopsy",
            "criterions": [
                {
                    "exact_snippets": "No history of prior prostate biopsy",
                    "criterion": "history of prior prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of genitourinary cancer, including prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "No history of genitourinary cancer",
                    "criterion": "genitourinary cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindications to biopsy",
            "criterions": [
                {
                    "exact_snippets": "No contraindications to biopsy",
                    "criterion": "contraindications to biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindications to mpMRI",
            "criterions": [
                {
                    "exact_snippets": "No contraindications to mpMRI",
                    "criterion": "mpMRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study",
            "criterions": [
                {
                    "exact_snippets": "No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment",
                    "criterion": "mpMRI for clinical investigation of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of prior prostate biopsy",
            "criterions": [
                {
                    "exact_snippets": "History of prior prostate biopsy",
                    "criterion": "prior prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of genitourinary cancer, including prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "History of genitourinary cancer",
                    "criterion": "genitourinary cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications to biopsy",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to biopsy",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications to mpMRI",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to mpMRI",
                    "criterion": "mpMRI",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}